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ENtiCe Project - Encouragement for Nicotine Cessation in pregnant smokers

In a community sample of pregnant women who are current smokers, does receipt of a larger Personal-Financial Incentive compared to a smaller Personal-Financial Incentive and no Personal-Financial Incentive illustrate a trend in increasing cessation rates: A Proof-Of-Concept trial

Status
Not yet recruiting
Phases
Unknown
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12612000399897
Acronym
ENtiCe
Enrollment
90
Registered
2012-04-10
Start date
2012-04-30
Completion date
Unknown
Last updated
2020-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief summary

This study aims to conduct a feasibility trial to test the efficacy of a Personal Financial Incentive (PFI)-based intervention at increasing smoking cessation in pregnant women attending a public hospital for antenatal care. Ninety consenting women will take part in the trial, with 30 women being randomised into one of three groups: the control group, the small PFI group and the larger PFI group. Women in the intervention groups will be eligible to receive a total of eight PFIs, if they successfully abstain from smoking for a 7 day period. Each time a participant in the intervention groups abstains from smoking their PFI will increase. As this is a Proof-Of-Concept study the main aim of the trial is to assess the viability and acceptability of this intervention.

Interventions

Participants will be randomised to one of three trial conditions (smaller incentive vs. larger incentive vs. control). There will be two intervention groups, both of which will involve provding a Personal-Financial Incentive (PFI) to pregnant women who successfully abstain from smoking. The first intervention will involve a smaller PFI. Women randomly allocated to this first intervention group will be provided with the opportunity to receive a PFI at eight out of 10 study sessions, contingent

Participants will be randomised to one of three trial conditions (smaller incentive vs. larger incentive vs. control). There will be two intervention groups, both of which will involve provding a Personal-Financial Incentive (PFI) to pregnant women who successfully abstain from smoking. The first intervention will involve a smaller PFI. Women randomly allocated to this first intervention group will be provided with the opportunity to receive a PFI at eight out of 10 study sessions, contingent upon smoking abstinence. This study will involve 10 study sessions 8 of which will be intervention sessions. The amount of the monetary reward will begin at $20 and will increase by a further $20 at every intervention follow-up session participants are found to abstain from smoking. Smoking abstinence will be assessed through a self-report survey and confirmed by saliva cotinine analysis. At each of the eight intervention follow-ups, women who biochemically-validated self-report smoking abstinence will receive their potential incentive for that follow-up period (i.e. $20 for the first follow-up). Eight intervention study sessions where women are eligible to receive a reward will be conducted. They will be conducted at study sessions held during womens scheduled antenatal appointments. These eight intervention study sessions will provide participants with an opportunity to receive a total of $720 if they cease smoking for the entire study period. The second intervention group will involve a larger PFI. Women randomly allocated to this second intervention group will be provided with the opportunity to receive a PFI at the eight intervention study sessions, contingent upon smoking abstinence. The amount of the monetary reward will begin at $40 and will increase by a further $40 at the eight intervention follow-up participants are found to abstain from smoking. Smoking abstinence will be assessed through a self-report survey and confirmed by saliva cotinine analysis. At each intervention follow-up, women who biochemically-validate self-report smoking abstinence will receive their potential incentive for that follow-up period (i.e. $40 for the first follow-up). Eight study sessions where women are eligible to receive a reward will be conducted (out of a total of 10 sessions). The intervention sessions will be conducted during womens scheduled antenatal appointments. These eight intervention study sessions will provide participants with an opportunity to receive a total of $1440 if they cease smoking for the entire study period. If a participant in both intervention groups fail to abstain at one of these eight intervention study sessions or do not present for their scheduled follow-up they will not receive the incentive for that period. However the incentive scheme will only ‘re-set’ to the amount the women were previously up to, therefore providing women with an opportunity to receive their incentive during their next intervention study session.

Sponsors

University of Newcastle
Lead SponsorUniversity

Study design

Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Prevention
Masking
Open (masking not used)

Eligibility

Sex/Gender
All
Age
16 Years to No maximum
Healthy volunteers
No

Inclusion criteria

Pregnant women will be considered eligible if they are: * Aged 16 years or older * Presenting for their first antenatal visit * Less than 31 weeks gestation * Sufficient English to complete the survey * Current smokers (defined as having smoked in last 7 days and a positive saliva test for cotinine).

Exclusion criteria

Pregnant women will be ineligible to participate if they: * Are considered by clinic staff to have a severe cognitive or psychiatric disorder * Currently being treated for chemical dependency other than alcohol or tobacco * Have quit smoking before their first antenatal appointment

Outcome results

None listed

Source: ANZCTR · Data processed: Mar 25, 2026